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Taking people in Puerto RicoPhase 1/2

Tests BGB-B2033 alone or with tislelizumab in advanced solid tumors

Tests BGB-B2033, alone or with other drugs, in adults with advanced cancers.

Key facts

Who runs it
BeOne Medicines
Where
Rio Piedras, Puerto RicoSee the siteAlso in 8 other countries, 49 sites
Trial code
Registry title
A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors
Status
Recruiting
Phase
Phase 1/2
People taking part
630 people, planned
Started
23 Jul 2024
Expected to end
31 Oct 2028
Type of study
Interventional, 7 groups
Treatments tested
  • BGB-B2033
  • Tislelizumab
  • Bevacizumab
Record updated
16 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or spread liver cancer, AFP-producing stomach cancer, germ cell tumors such as extragonadal yolk sac tumors, or GPC3-positive squamous lung cancer.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Tumors that cannot be removed by surgery, are locally advanced or have spread. Liver cancer: BCLC Stage C, or Stage B that cannot have or has progressed after local liver treatment. Germ cell tumors: no other treatment meant to remove all of the disease is left. Lung cancer: squamous type.
Earlier treatment
Squamous lung cancer: must have had a checkpoint inhibitor before. Germ cell tumors: no further systemic treatment meant to remove all of the disease. Cannot have had earlier treatment aimed at glypican-3 (GPC3) or 4-1BB (CD137).
Biomarker or test result
Stomach cancer: AFP above 20 ng/mL in blood, or tumor tissue positive for AFP. Lung cancer: tumor positive for GPC3. A tumor tissue sample is needed for some parts of the study.

Main reasons for not taking part

  • Earlier treatment aimed at GPC3 or 4-1BB (CD137)
  • Active leptomeningeal disease or untreated or uncontrolled brain metastases
  • Active autoimmune disease, or past autoimmune disease that could return
  • Another cancer diagnosed 2 years or less before the first dose, with some exceptions
  • Steroids above 10 mg/day prednisone or equivalent, or other immune-suppressing treatment, within 14 days before the first dose

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • Participants must have one of the following unresectable, locally advanced, or metastatic tumor types:; Hepatocellular carcinoma (HCC): Histologically or cytologically confirmed HCC that is either Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not amenable to, or has progressed after, loco-regional therapy and is not eligible for a curative treatment approach; Alpha-fetoprotein (AFP)-producing gastric cancer (GC): Histologically confirmed GC with AFP > 20 ng/mL in blood or tumor tissue positive for AFP by a validated immunohistochemistry (IHC) assay based on local or central testing; Germ cell tumors: Histologically confirmed germ cell tumors including extragonadal yolk sac tumors (e.g., located in the mediastinum, vagina, brain, retroperitoneum), and non-dysgerminomas for which no further curative systemic treatment options exist; Glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC): Histologically confirmed GPC3-positive squamous NSCLC with prior exposure to a checkpoint inhibitor (CPI)
  • At least one evaluable lesion for dose escalation, and at least one measurable lesion for safety expansion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  • Adequate organ function as defined in the protocol
  • Provision of tumor tissue samples is required for specified parts of the study

Who cannot take part

  • Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137)
  • Any malignancy diagnosed ≤ 2 years before the first dose of study drug(s), except: The cancer type under investigation in this study, or Locally recurring malignancies previously treated with curative intent
  • Requirement for systemic corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to the first dose of study drug(s)
  • Active leptomeningeal disease or uncontrolled/untreated brain metastases
  • Active autoimmune disease or a history of autoimmune disease with potential for relapse
  • Certain comorbidities involving the lungs, heart, bleeding conditions, or active infections, as defined in the protocol; Note: Additional protocol-defined inclusion and exclusion criteria may apply

Where in Puerto Rico

Also in 8 other countries, 49 sites

  • Hospital OncologicoRio Piedras, Puerto RicoContact: Study DirectorTaking people

About the trial

What the trial wants to find out

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BGB-B2033 alone or in combination with tislelizumab, with or without bevacizumab, in adults with advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors, non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC). The study will also determine the recommended Phase 2 dose (RP2D) of BGB-B2033 when given alone or in combination with tislelizumab and bevacizumab. The main questions it aims to answer are:

Read full original descriptionShow less

* Is BGB-B2033 safe and tolerable when given alone or in combination with tislelizumab, with or without bevacizumab? * How does the body process BGB-B2033, and what are its effects on the body? * Does BGB-B2033 show preliminary antitumor activity in participants with advanced or metastatic cancer?

Researchers will evaluate different doses and treatment combinations to determine the safest and most appropriate dose of BGB-B2033 for further study.

Participants will:

* Receive BGB-B2033 by intravenous infusion, either alone or in combination with tislelizumab, with or without bevacizumab. * Have regular assessments to monitor safety, side effects, how their body processes and responds to BGB-B2033, and whether their cancer responds to treatment.

The 7 groups in the trial

  • Part A (Monotherapy Dose Escalation and Safety Expansion)Treatment being tested

    Participants will receive ascending dose levels of BGB-B2033 monotherapy

    Treatment: BGB-B2033

  • Part B (Doublet Run-in)Treatment being tested

    Participants will receive BGB-B2033 in combination with tislelizumab and to inform the starting dose of BGB-B2033 for subsequent triplet dose escalation.

    Treatment: BGB-B2033 and Tislelizumab

  • Part B (Triplet Dose Escalation)Treatment being tested

    Participants will receive BGB-B2033 in combination with tislelizumab and bevacizumab to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), and recommended dose for expansion (RDFE) of the combination.

    Treatment: BGB-B2033, Tislelizumab, and Bevacizumab

  • Part B (Triplet and Doublet Safety Expansion)Treatment being tested

    Safety expansion arm for each combination therapy cohort (triplet and doublet)

    Treatment: BGB-B2033, Tislelizumab, and Bevacizumab

  • Part C (Asia Monotherapy Dose Expansion in HCC)Treatment being tested

    Participants in Asian countries with HCC will receive BGB-B2033 as monotherapy.

    Treatment: BGB-B2033

  • Part D (US Monotherapy Dose Expansion in HCC)Treatment being tested

    Participants in the United States (US) with HCC will receive BGB-B2033 as monotherapy.

    Treatment: BGB-B2033

  • Part E (Monotherapy Dose Expansion in HCC)Treatment being tested

    Participants with HCC will receive BGB-B2033 as monotherapy.

    Treatment: BGB-B2033

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1/2 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Selected Advanced or Metastatic Solid Tumors
Plain-language title
Tests BGB-B2033 alone or with tislelizumab in advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
16 September 2026